Cleared Traditional

K862668 - HEALTHPHONE(TM)

K862668 is the FDA 510(k) clearance for HEALTHPHONE(TM) by Carelink. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K862668 · Carelink · Cardiovascular device
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Dec 1986
Decision
161d
Days
Class 2
Risk

K862668 is an FDA 510(k) clearance for the HEALTHPHONE(TM). Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Carelink (Anaheim, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Carelink devices

Submission Details

510(k) Number K862668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date December 22, 1986
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 103
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K862668.
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CARD GUARD, MODEL CG-2000
K882290 · Card Guard Scientific Survival , Ltd. · Jul 1988
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · Medtronic Vascular · May 1987
WEP 7604 TELEMETRY MONITOR
K854369 · Nihon Kohden America, Inc. · Feb 1986
CMS 8000
K853096 · Physio-Control Corp. · Jan 1986
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · Medtronic Vascular · Oct 1985